This Is MS

Oral Therapy Laquinimod to Start Phase III Trials for RRMS

The race for an oral multiple sclerosis medication took one further step today, when Teva and Active Biotech announced that they were going to begin the final Phase of clinical testing for their pill candidate, called laquinimod.

This followed the successful conclusion of Phase II, as well as consultations with the US FDA. Drugmakers are cautious...

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MS Walking Improvement Drug Gets FDA Help

Most of the MS therapies in the drug development pipeline, or even available today, are targeted at reducing relapses and decreasing disability progression.

Which makes Acorda Therapeutics' Fampridine-SR quite interesting. In Phase III trials, it is targeted specifically at one particularly onerous aspect of the MS burden-- impact on walking ability.

Acorda and the United States Food and Drug Administration recently reached an agreement on a pathway to getting Fampridine approved for this indication. In addition to a Phase III trial currently underway, Acorda will work with the FDA's Special Protocol Assessment (SPA) to ensure their trial design proves that individuals treated with Fampridine-SR are significantly more likely to have consistent improvements in their walking than those treated with placebo...

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Daclizumab Shows Promise in Phase II Trial for Relapsing Remitting MS

Just over a year ago, PDL Pharmaceuticals partnered with MS giant Biogen (Avonex, Tysabri) to bring a drug known as daclizumab through trials for MS. Daclizumab is today used for the prevention of kidney transplant rejection, under the marketing name Zenapax (r). The partnership seems to be bearing fruit, as the companies announced that Daclizumab hit its targets in its first Phase II multiple sclerosis trial.

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Minimal Changes in Cognitive Function of Relapsing-Remitting MS'ers in a 10-year

The question of cognitive decline as a result of MS is a serious one. If the accumulation of physical disability is a hallmark of the condition, its affect on cognitive dysfunction is not always so obvious. In fact, in a recent trial for Copaxone (glatiramer acetate) observing cognitive scores, the placebo group improved just as much as the Copaxone-treated group over two years. Perhaps 2 years was too short to see a difference, so a new study observed a group of MS'ers over TEN years.

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PML Seen with Rituxan for Lupus

Our old nemesis, progressive multifocal leukoencephalopathy, or PML, has reared its ugly head yet again, this time in association with another of Biogen's drugs, Rituxan.

PML, if you recall, was implicated in the multiple deaths associated with Tysabri last year, leading to its temporary suspension. After much analysis and an unprecedented patient board hearing by the FDA...

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Vitamin D Reduces Risk of Multiple Sclerosis

Numerous studies of MS have shown a correlation between disease frequency and geographic location, with the general rule being that as a person gets further away from the equator, their MS risk rises. This has often been reduced to sun exposure, with one of the more obvious implications being that sunlight causes the body to create Vitamin D--25-hydroxyvitamin D-- and therefore Vitamin D just might have a protective affect against MS.

A new study released yesterday provides compelling statistics behind that claim, saying in short that Vitamin D seems to reduce the risk of developing MS in Caucasians.. While the study does not make any claims about people who already have MS benefiting from Vitamin D supplementation...

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Opexa Begins Phase IIb Study on Tovaxin

Some positive news to share regarding the experimental multiple sclerosis therapy named Tovaxin. Tovaxin is a novel therapy that is individualized to each patient-- white blood cells are taken from the patient, altering them in the lab into a form that when reinjecting into the patient, willl elicit a response from the immune system against other white blood cells that attack myelin.

A new Phase IIb study has launched, intending to enroll 150 relapsing-remitting multiple sclerosis patients in a multicenter, placebo-controlled trial. It is a year-long study, where the medication is given (by subcutaneous injection) 5 times, at inception, then month 1, 2, 3 and 6. The primary endpoint is, as typical, the number of T1 enhancing (and thus active) lesions on MRI at various weeks after the final injection. Secondary endpoints include...

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Oral Therapy FTY720 (Fingolimod) Shows Promise for MS

Novartis announced this week that its experimental once-daily, oral multiple sclerosis therapy, Fingolimod, also known as FTY720, succeeded in its phase II clinical trial.

Fingolimod (which, by the way, wins our award for Most Unintentionally Humorous Drug Name) works by keeping the immune system's T cells in the lymph nodes and away from the central nervous system, which is for reasons yet unknown, vulnerable to attack in an MS patient.

The trial enrolled over 250 patients. In the first six months, patients were randomized to receive either one of two doses of fingolimod, or a placebo. For the following six months, all the placebo patients were randomized to one of the two fingolimod doses.

The results...

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Rituxan Has Positive Phase II Results

Biogen, and a new name in the multiple sclerosis world, Genentech, proudly announced today that their Phase II trial of Rituxan against Relapsing-Remitting MS (RRMS) was considered successful. Rituxan was originally approved as a cancer therapy versus non-Hodgkin's Lymphoma. More recently it received approval to treat Rheumatoid Arthritis in combination with methotrexate for patients failing standard therapies.

Rituxan works by depleting B-cells, a type of white blood cell associated with inflammation.

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Teva to Examine Neutralizing Antibodies to Interferon

In what at first seems like a contradiction, Teva, manufacturer of the multiple sclerosis treatment Copaxone, is now enrolling for a large trial examining so-called Neutralizing Antibodies (NAbs) to high-dose Interferon-beta. Copaxone, or glatiramer acetate, is notable for being the only mainline therapy that is not an interferon (excluding for the time being Tysabri and Novantrone).

NAbs, when present, have been shown to negatively affect the therapeutic value of the interferon drugs, developing in somewhere between 5-45% of patients receiving interferon treatments like Avonex, Betaseron and Rebif. Teva contends that though the impact of the NAbs is gigantic, testing for their presence is not routine.

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